Global Medical Device Podcast powered by Greenlight Guru

416 Episoder

1. How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

   Udgivet: 7.11.2019
2. Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

   Udgivet: 7.11.2019
3. How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

   Udgivet: 7.11.2019
4. How FDA Interacts with Medical Devices When They Are Imported into the US

   Udgivet: 7.11.2019
5. Understanding the Connection Between Complaints, CAPAs, and MDRs

   Udgivet: 7.11.2019
6. The Intersection of Medical Device Usability and Risk Management

   Udgivet: 7.11.2019
7. When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

   Udgivet: 7.11.2019
8. Understanding FDA’s Proposed Conformity Assessment Pilot Program

   Udgivet: 7.11.2019
9. Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

   Udgivet: 7.11.2019
10. Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

    Udgivet: 7.11.2019
11. Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

    Udgivet: 7.11.2019
12. How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

    Udgivet: 7.11.2019
13. Lessons to Be Learned From Recent FDA Inspections

    Udgivet: 7.11.2019
14. How Process Excellence Leads to Product Excellence

    Udgivet: 7.11.2019
15. Common Mistakes That Can Tank Your FDA 510(k) Submission

    Udgivet: 7.11.2019
16. Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

    Udgivet: 7.11.2019
17. Challenges with Applying Risk Management Throughout the Manufacturing Process

    Udgivet: 7.11.2019
18. An Overview of What Medical Device Developers Need to Know About Human Factors

    Udgivet: 7.11.2019
19. Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

    Udgivet: 7.11.2019
20. What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important

    Udgivet: 7.11.2019